Indian API Manufacturer Fails to Correct Significant GMP Deviations, Receives FDA Warning Letter

FDA Warns Indian API Manufacturer of Several Serious GMP Violations

In May 2016, the FDA inspected Resonance Laboratories Pvt. Ltd.’s Bangalore manufacturing facility.  During this inspection, the FDA investigator observed a number of significant deviations from current good manufacturing practices (CGMP) for active pharmaceutical ingredients (APIs).  On May 26, 2016, the company responded to FDA’s findings.

On February 3, 2017, FDA issued a Warning Letter to Resonance, stating that its response was inadequate.  In the letter, FDA notes that although the company “committed to addressing issues identified with the water systems and cleaning validation,” the overall response “lacked details.”  Furthermore, the company’s response did not include a retrospective review of CGMP deficiencies for the quality of its products that are already being distributed in the US.

During the inspection, FDA notes that the following deviations were observed:

“Failure to validate that your water system is capable of consistently producing water suitable for its intended use.”

  • The APIs manufactured by Resonance are used in the production of sterile drug products. However, the company failed to demonstrate that the distilled water used to clean equipment is suitable for use.

“Failure to have adequate cleaning procedures to prevent contamination or carry-over of a material that would alter the quality of the API.”

  • Resonance uses shared equipment to manufacture its APIs. However, FDA notes that data from cleaning verification and validation studies found the company’s cleaning procedures to be ineffective.

Upon receipt of the letter, Resonance was given 15 working days to respond to FDA’s Center for Drug Evaluation and Research (CDER), specifying what has been done to correct the deviations and to prevent them from reoccurring.  If the company is unable to complete the corrective actions within the time frame provided, Resonance must provide an explanation for the delay as well as a schedule for completion.

If the company fails to correct these deviations, FDA may refuse the admission of products manufactured at Resonance’s Bangalore facility into the US.

Based on the nature of the deviations identified during the inspection, FDA strongly recommended that Resonance engage an FDA consultant to assist the company in meeting the Agency’s CGMP requirements.  Are you in a similar situation and in need of assistance?  We can help you achieve and maintain compliance with FDA’s CGMP and all other regulations.  Do you want to prevent this type of situation from occurring to your firm? We are qualified and capable of helping you develop and implement a quality system to ensure a successful FDA inspection.  To learn more about our services and how we can help with all of your quality and compliance needs, contact us today.